Job Title: Senior Consultant – Computer System Validation (CSV)

Location: Montreal, Canada (Hybrid)

Duration: 12 months, plus extensions

Experience: 10+ Years

Domain: Pharma / Healthcare / Life Sciences

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We are looking for an experienced Senior Consultant with strong expertise in Computer System Validation (CSV), GxP compliance, and GAMP 5 guidelines to support validation activities and SAP ecosystem data migration.

Mandatory Skills:

- Robust hands-on experience in Computer System Validation (CSV).
- Deep knowledge of GxP (GMP, GCP, GLP) regulations.
- Strong understanding of GAMP 5 guidelines.
- Experience validating GxP computerized systems.
- Hands-on experience preparing and reviewing URS, FS, FRA, DD, IQ, OQ, PQ, and TRM documents.
- Experience creating Validation Plans and Validation Reports.
- Knowledge of quality assurance, compliance audits, and CAPA.
- Experience supporting SAP ecosystem data migration.
- Strong Pharma / Healthcare / Life Sciences domain experience.

📌 Senior Consultant – Computer System Validation (CSV) Montreal, Canada (Hybrid)
🏢 Burgeon IT Services
📍 Montreal